Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT04834856
Eligibility Criteria:
Inclusion Criteria:
* Men or non-pregnant women, between 18 and 70 years on the day of inclusion.
* Presence of one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion.
* Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).
Exclusion Criteria:
* Requiring hospitalization at time of screening, or at time of study drug administration.
* Oxygen saturation (SpO2) ≤ 93 percent (%) on room air at sea level, respiratory rate ≥ 30 per minute, or heart rate ≥125 per minute.
* Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
* Any co-morbidity requiring hospitalization or surgery within \<7 days, or that is considered life-threatening within 29 days.
* A patient reported history (prior to the current episode) of a positive SARS-CoV-2 serology test or a history of PCR confirmed SARS-CoV-2 infection.
* Prior or concurrent use of SARS-CoV-2 antiviral medication, including convalescent serum or anti-viral antibodies.
* Concurrent enrollment in any other type of medical research for improving COVID-19 outcomes or that is judged by the investigator not to be scientifically or medically compatible with this study.
* Women that are currently breast feeding, pregnant, or plan to get pregnant during the duration of the trial.
* Severe immunocompromised status (primary immunodeficiency, supraphysiological dose of systemic corticosteroids, transplant patients, known untreated HIV and CD4 T-cells \<200/microliter) or use of any immunosuppressants that, in the opinion of the investigator, should preclude participation in this study.
* Subjects at high risk for of COVID-19 related complications or mortality
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04834856
Study Brief:
Protocol Section:
NCT04834856